TheraRadar
Data updated: May 26, 2026

GALZIN (zinc acetate)

Rare Disease Approved 1997-01-28

GALZIN is indicated for the treatment of Wilson's Disease.

1
Indication
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1997-01-28
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: ZINC ACETATE

GALZIN Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
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2021
2022
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2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 1997 to 2024
Apr 2024 SUPPL
Label · Labeling
Jan 2016 SUPPL
Mfg · Manufacturing (CMC)
May 2015 SUPPL
Mfg · Manufacturing (CMC)

What GALZIN Treats

1 indications

GALZIN is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Wilson's Disease
Source: FDA Label

GALZIN Competitive Set

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Indication competitors

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Same indication, different mechanism — what else might this patient receive?

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to GALZIN

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

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TRIENTINE TETRAHYDROCHLORIDE
1 shared
ORPHALAN
Shared indications:
Wilson's Disease
PENICILLAMINE
PENICILLAMINE
1 shared
INVAGEN PHARMS
Shared indications:
Wilson's Disease
TRIENTINE HYDROCHLORIDE
TRIENTINE HYDROCHLORIDE
1 shared
CHARTWELL RX
Shared indications:
Wilson's Disease
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT02868151 ECR/227/INSP/AP/2014 Ph 2, Ph 3 completed Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers
NCT00696410 results posted HUM0001911 NIHT32-HL007853 Ph 1 completed The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

GALZIN FDA Label Details

Indications & Usage

FDA Label (PDF)

GALZIN is indicated for the treatment of Wilson's Disease.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.